OBJECTIVES: This study aimed to i) analyse the research questions and methods in recent qualitative in-trial interviews (ITI) study publications and ii) identify the value that ITI studies provide during clinical development.

METHODS: ITI studies published in the last 10 years were identified via PubMed search. Further screening was conducted to select qualitative studies involving patient interviews associated with a clinical trial. Extracted data included therapeutic area, ITI’s research questions, design, execution, and characteristics of the clinical trials in which the interviews were conducted.

RESULTS: Fifteen publications were included covering a range of diseases (oncology, mental health, diabetes, gynaecology, and Alzheimer’s disease). The ITI studies were conducted at different timepoints in the trial (baseline, mid-point, exit interviews), and most commonly in drug trials across all phases of clinical development. The main objectives were to understand patients’ experiences with the disease, treatments, and the clinical trial, as well as patient preference. Exit interviews were most frequently conducted (n=9). Three studies included interviews conducted at multiple timepoints (e.g., baseline and exit interviews). Nine ITI studies were considered part of the trial and included in the clinical study protocol (CSP), rather than as stand-alone studies, but patients could be in the trial without consenting to the interviews. On average, ~9% of trial participants were included in the ITI study, commonly via non-probability sampling. Eight studies used semi-structured interview guides. Seven studies informed the mode of interviews (either via telephone (n=5) or face-to-face (n=2)). One study explicitly referred to GDPR and GCP compliance measures and two studies mentioned safety reporting procedures.

CONCLUSIONS: ITI studies are being used in clinical development to help understand patient experience and preference. Interviews can be conducted as part of the clinical trial, or as a stand-alone study. When to conduct interviews depends on the research questions and operational considerations.